Weill Cornell Researchers: Velcade + PD 0332991 Weaken & Defeat Myeloma Cells, Potential for Lymphoma

In laboratory experiments, researchers at Weill Cornell Medical College have demonstrated that the cancer fighting effects of Velcade (bortezomib) and PD 0332991  were exponentially multiplied when used together in their laboratory studies on multiple myeloma tumor cells.

The normal cellular growth cycle is derailed in cancer. Uncontrolled growth and multiplication is often the result. The researchers found that PD 0332991 stops the cellular cycle in a vulnerable moment, leaving the cancer cell wide open for cellular destruction by Velcade.

The study, published online last month by the journal Blood, is the first to show that precise timing of therapies that target a cancer cell’s cycle — the life phases leading to its division and replication — disables key survival genes, resulting in cell death. The drug that delivers the weakening jab at the cell cycle is the experimental agent PD 0332991, which allows Velcade, a proteasome inhibitor already approved for use in myeloma and lymphoma, to land the final defeating blow at lower than normal doses.

Dr. Selina Chen-Kiang, professor of Pathology and Laboratory Medicine and of Microbiology and Immunology at Weill Cornell Medical College was the lead scientist on the study. In an interview Dr. Chen-Kiang said:

“Because robust functioning of the cell cycle is crucial to cancer growth and survival, this mechanism-based strategy could theoretically be used against many kinds of cancers.”

The same combination is being tested in patients with mantle cell lymphoma in a Weill Cornell investigator-initiated study led by Dr. John Leonard. Click here for more information about the mantle cell lymphoma study.

 

New Clinical Trial: GS-1101 (CAL-101) + Rituximab for Previously Treated CLL

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS 1101 (CAL 101) in Combination with Rituximab for Patients with Previously Treated Chronic Lymphocytic Leukemia

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now enrolling patients in a new clinical trial for people with previously treated Chronic Lymphocytic Leukemia (CLL). The sponsor is Gilead Sciences, and the principal investigator at Weill Cornell is Dr. Richard Furman. For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at amr2017@med.cornell.edu.

Study Details

The study will evaluate the effectiveness of the experimental drug GS-1101 (CAL-101) combined with rituximab in treating CLL.

GS-1101 (CAL-101) is a pill designed to block some of the cell functions that cause CLL to grow and survive and may help control the disease. Rituximab is FDA-approved as a treatment for CLL. It is possible that giving rituximab together with GS-1101 may have more activity against the CLL disease process than giving rituximab alone.

Study participants will be randomly assigned to one of two treatment groups:

  • Group A: rituximab and GS-1101
  • Group B: rituximab and placebo (an inactive pill that looks like GS-1101 but contains no medicine)

Treatment Plan

All study participants will receive rituximab via infusion 8 times over 24 weeks: Day 1, then Weeks 2, 4, 6, 8, 12, 16 and 20.

Participants will take GS-1101 or placebo twice daily for 24 weeks.

After 24 weeks of therapy with rituximab and GS-1101 or placebo, participants will continue on GS-1101 or placebo as long as their CLL is controlled. If their CLL gets worse, participants may be able to take part in a separate extension study where they receive GS-1101 at a higher or lower dose. Thus, everyone who is treated in this study has an opportunity to receive active GS-1101, either in the main study or the extension study.

ASCO Update: Lenalidomide + Rituximab Superior to Lenalidomide Alone in Relapsed Lymphoma

John Leonard, MD

At the recent meeting of the American Society of Clinical Oncology (ASCO), Dr. John Leonard, the director of the Weill Cornell Lymphoma Program, presented the results of the CALGB 50401 trial. The trial compared lenalidomide plus rituximab versus lenalidomide alone in 94 patients with previously treated follicular lymphoma.

Although significant side effects were similar in both treatment arms, the patients treated with the lenalidomide plus rituximab were more likely to respond to treatment (75% vs. 49%) and remain on treatment compared to lenalidomide alone. Based on these results, the investigators concluded that the lenalidomide-rituximab regimen should be considered as a platform for addition of new drugs in future studies.

Click here to read the published abstract.